Pneumococcal Infections
Conditions
Keywords
Pneumonia, Pneumococcal
Brief summary
Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world. This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.
Interventions
0.5mL, Intramuscular
Sponsors
Hunan Provincial Center for Disease Control and Prevention
Liaoning Chengda Biotechnology CO., LTD
Wuhan BravoVax Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
One arm, open label in subjects aged 3 months and above; Randomized, blinded and active comparator in subjects aged 2 months.
Eligibility
Sex/Gender
ALL
Age
6 Weeks to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Satisfy the age requirements of the clinical trial; willing to provide proof of identity; * Subjects or guardians must provide informed consent forms with personal signature and date; * Male and female of childbearing age should agree to take effective contraception measures; * Subjects or guardians can obey the requirements of the clinical study; * Axillary temperature below 37.3 °C.
Exclusion criteria
* Laboratory indicators (expect those have no clinical significance) out of normal ranges required; * Received any pneumococcal vaccine; * Allergic history to any drugs, vaccine or vaccine-related component; * Infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition; * Infants diagnosed with pathological jaundice that lasts for 2\ 4 weeks and occurs repeatedly; * Breast-feeding or pregnant women, or positive U-HCG; * High blood pressure uncontrolled by medication; * Known or suspected immune deficiency or immune suppression; * Serious congenital malformation, history of organ resection or serious chronic illness; * Received blood products or intravenous immunoglobulin (except Hepatitis B immunoglobulin); * History of clinic-proven or serology-proven infectious disease especially caused by streptococcus pneumoniae; * History of convulsions, epilepsy or encephalopathy or a family history of mental illness; * A vaccination-related contraindications that other investigator believes; * Plans to participate in or is participating in any other clinical study; * Any other factors judged by investigator that may interfere subject's compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety in terms of laboratory-based AEs | within 4 days post each vaccination | Occurrence of laboratory-based AEs in subjects of 2 years old and above(Arm 1A-3A) |
| Safety in terms of adverse reactions | within 30 minutes post each vaccination | Occurrence of AEs on vaccination site (local) and non-vaccination site (systemic) of each subject |
| Safety in terms of adverse events | within 7 days post each vaccination | Occurrence of solicited AEs of each subject |
| Safety in terms of SAEs | within 6 months post last vaccination | Occurrence of SAEs of each subject |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogencity in terms of seropositivity rates by ELISA | 30 days post basic vaccination | Seropositivity rates of serotype-specific pneumococcal IgG antibody in subjects of each age group |
| Immunogencity in terms of GMC by ELISA | 30 days post basic vaccination | GMC of serotype-specific pneumococcal IgG antibody in subjects of each age group |
| Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL | 30 days post basic vaccination | Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL |
| Immunogencity Comparison with control vaccine group | 30 days post basic vaccination | Comparison of the seropositivity rates, GMC of serotype-specific pneumococcal IgG antibody and the Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL in subjects aged 2 months of Experimental group and Control group |
Countries
China
Contacts
Primary ContactLong Xu, Ph.D.
Outcome results
None listed